Premier, Inc., is an alliance of inpatient facilities that has team up with the Centers for Medicare and Medicaid Services (CMS) on a pay-for-performce pilot called the Hospital Quality Improvement Demonstration. Premier reported on the pilot’s results today.

According to Premier’s analysis, if all pneumonia, heart bypass, heart attack (acute myocardial infarction), and hip and knee replacement patients nationally received most or all (76 to 100 percent) of a set of widely accepted care processes in 2004, it could have resulted in nearly 5,700 fewer deaths; 8,100 fewer complications; 10,000 fewer readmissions; and 750,000 fewer days in the hospital. In addition, hospital costs could have been as much as $1.35 billion lower. While the study findings from patients receiving care for pneumonia, heart bypass, heart attack and hip and knee replacement procedures are extremely positive, the findings from heart failure patients demonstrate a need for continued evaluation into the relationship between improved process delivery and outcomes.

The complete report is available here.

As I predicted, Judge Stein did issue this afternoon a preliminary injunction barring further Apotex sales of its generic version of the anti-coagulant drug Plavix. However, the Judge denied Bristol Myers motion for an order requiring a recall of the generic Plavix pills that already have been distributed. (Sanofi-Aventis v. Apotex, Inc., Civil Action No. 02-CV-2255 (SHS) (S.D.N.Y.) The Judge’s order can be immediately appealed to the U.S. Court of Appeals for the Second Circuit. Absent a successful appeal, the injunction will remain in force until the end of the patent dispute. The trial is set for January 2007.

CBS Marketwatch had reported a significant drop in brand name Plavix sales preceding the issuance of this order. As I previously mused, the Court’s order is similar to closing the barn door after the horse is gone as massive quantities of the generic Plavix are now on the market.

The August 31, 2006, issue of the New England Journal of Medicine includes a study on U.S. health care spending since 1960. The report, prepared by a Harvard economist, a Veterans Affairs Department public health expert, and a University of Michigan research physician “compared gains in life expectancy with the increased costs of care from 1960 through 2000.” The report surprisingly concludes that “On average, the increases in medical spending since 1960 have provided reasonable value” in terms of increased life span. The study has attracted a lot of press attention.

According to the Los Angeles Times, the journal Science announced today that Dr. Stephen A. Rosenberg and other research physicians at the National Cancer Institute treated two potentially fatal cases of the aggressive skin cancer advanced melanoma by genetically altering the patients’ white blood cells to attack the cancer tumors. However, the treatment failed on fifteen other patients, and while the two patients who were treated successfully have remained disease free for two years, there is no guarantee that the cancer will not reoccur. Nevertheless, scientists reportedly are very excited (and so am I) because this is the first major successful use of gene therapy against a deadly cancer. Bravo!

One of the new Medicare Advantage options for seniors is the Private Fee for Service Plan. The insurance company offers a traditional indemnity plan, and the providers have to accept Medicare level reimbursement. The Wall Street Journal reports today that seniors are flocking to these plans. (The link is to a reprint in the Pittsburgh Post Gazette that works.)

The Journal article quotes David Lewis, acting director of the Medicare Advantage Group at the Centers for Medicare and Medicaid Services (Mr. Lewis previously was an FEHBP Contracting Officer), “Enrollment in private fee-for-service plans alone jumped to 802,068 as of Aug. 1 from just 20,000 three years ago.” Wellpoint, Aetna, and Humana are expanding their private FFS offerings.

The illuminating article explains

As with most [Medicare] Advantage plans, premiums are often lower than the combined premiums for government-run Medicare benefits for physician and hospital services and drugs. Advantage members must still pay the Medicare part B premium for physician and outpatient services, which is $88.50 a month. But Advantage plans may wrap in other benefits such as additional days in the hospital and drugs. As insurers expand their private fee-for-service offerings, the plans will see “dramatic growth” next year, says Dan Mendelson, president of Avalere Health. But some wonder how long seniors can take advantage of this program. The Medicare Payment Advisory Commission, which advises the government on Medicare, has warned that the government pays 11 percent more on average to Medicare Advantage plans for physician and hospital services than the traditional ones.

I wonder how many FEHBP eligible annuitants have dropped their FEHBP coverage in favor of a Medicare private FFS plan? Under OPM’s rules, an annuitant can suspend his or her FEHBP coverage to enroll in a Medicare Advantage plan with the option to later reenter the FEHBP. Under the general rule, if an annuitant drops FEHBP coverage, the decision is permanent.

The U.S. Attorney for the District of Massachusetts announced earlier today that the Schering Sales Corp., a subsidiary of the Schering-Plough Co., a major drug manufacturer, has agreed to plead guilty to a criminal conspiracy charge and pay a $180,000 criminal fine. Schering-Plough has agreed to settle False Claims Act charges by paying $159,502,000, plus interest, to the United States in civil damages for losses suffered by the Medicare program, the federal portion of the Medicaid program, the Veteran’s Administration, the Department of Defense and the Federal Employees Health Benefits program as a result of Scherings’s improper drug promotion and marketing misconduct. Schering-Plough’s payments to the Government total $435,000,000. These appear to be the Government’s False Claim Act claims that related to the FEHBP as described in the government’s press release:

• Schering induced physicians to start patients on Intron A for Hepatitis C by paying them remuneration through three marketing programs.
• Schering induced physicians to use Temodar for certain patients with brain tumors and brain metastases and to use Intron A for certain patients with superficial bladder cancer through improper preceptorships, sham advisory boards, lavish entertainment, and improper placement of clinical trials; and
• Schering knowingly promoted off label uses of Temodar for certain brain tumors and brain metastases and Intron A for superficial bladder cancer despite not having FDA approval.

Schering Plough subsidiary Schering Sales Corp. also was debarred from participating in federal health care programs.

As I blogged this week, August 2006 marks the 10the anniversary of the Health Insurance Portability and Accountability Act (HIPAA) as well as Tiger Woods’ entry into the world of professional golf. HIPAA provides for four standard identifiers to be used with the standard transactions:

1. Standard employer identifier, which is the employer’s employer identification number — the compliance date for use of this identifier was July 30, 2004 (July 30, 2005 for small health plans as defined by HIPAA).

2. Standard provider identifier, which is an “intelligence-free” ten digit number — the compliance date for use of this identifier is May 23, 2007 (May 27, 2008. for small health plans). The National Uniform Claim Committee has created a revised HCFA 1500 claim form (8/05) which incorporates the HIPAA standard provider identifier. According to NUCC’s recommended timeline, health plans, clearinghouses, and information support vendors are expected to be able to receive the revised HCFA form on October 1, 2006.

3. Standard health plan identifier, which has not yet been proposed by HHS., and according to an American Bar Association report, HHS has no plans to issue this identifier in the near future because there is no industry push for this identifier. However, I understand from health plan clients that this identifier would be useful for coordination of benefits purposes.

4. Standard patient (or individual) identifier, which has not yet been proposed by HHS because since 1998 Congress has prohibited HHS from spending appropriated funds on this initiative. However, the day of reckoning may be approaching because the national health information network, a major HHS goal, will need a standard patient identifier or other means of patient identification in order to operate.

The U.S. Office of Personnel Management has posted its observations on implementing the President’s recent Executive Order about health care quality and pricing tranparency and health information technology interoperability. Also available online are the President’s remarks on the Executive Order also are online and the transcript of a “press gaggle” aboard Air Force One during which HHS Secretary Leavitt describes the Executive Order as “a significant step toward an interoperable system of value-based competition.”

Judge Stein has not ruled on the Bristol Myers preliminary injunction motion in the Plavix patent infringement case. I took a look at the court’s docket today (Sanofi-Aventis v. Apotex, Inc., Civil Action No. 02-CV-2255 (SHS) (S.D.N.Y.) I surprised to find that the National Association of Chain Drug Stores had filed an amicus brief in opposition to the preliminary injunction motion. The brief argues that Bristol Myers lacks the “clean hands” necessary to obtain such equitable relief and that chain drug stores and their customers would be harmed by the entry of a preliminary injunction that would cause Plavix prices to jump.

Earlier this week, I wrote about the potential public health advantages of electronic medical records and the President’s Executive Order encouraging improvement in health care quality. Health insurers are not waiting for the National Health Information Network to be established in order to reap public health benefits from claims data. I should have mentioned at the time that the Blue Cross Blue Shield Association recently announced that it is pooling its claims data (without personal identifiers) in an effort to help employers and other health care consumers improve the quality of health care. Similarly, a coalition of employers and insurers organized by Mercer Human Resources Consulting under the banner Care Focused Purchasing Inc. has created a similar data warehouse for health care quality improvement purposes. These efforts build on the work of organizations such NCQA and the Leapfrog Group.